Physical Activity Levels of Parents of Children With Cystic Fibrosis- (PHACTS-CF)

Cystic Fibrosis in Children Clinical Trial

— PHACTS-CF  

Official title:

Investigating Physical Activity Levels of Parents of Children With Cystic Fibrosis and Its Influence on Their Children's Physical Activity Levels and Nebuliser Use

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05493137
• Other study ID #: A096376
• Status: Not yet recruiting
• Start date: October 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: August 2022
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: Kieren Lock, Bsc
• Phone: 01223256726
• Email: kieren.lock[@]addenbrookes.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will investigate if parental physical activity levels, assessed by providing a physical activity questionnaire to parents of children aged 6-16 with Cystic Fibrosis (CF), is associated with their child with CF's physical activity levels. Children's activity levels will be taken from electronic records where a questionnaire is routinely given at annual reviews to analyse this. Parental activity levels will also be compared against adherence to nebulisers as a proxy for adherence to treatment, this data is again in the electronic records of patients and is collected at annual reviews.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

Inclusion Criteria:

1. Parents of Children aged 5-16 years.

2. Under the care of Cambridge University Hospitals CF team

3. Confirmed Cystic Fibrosis diagnosis

4. Uses an ineb as main nebulizer delivery device.

5. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

1. Parents of CYP diagnosed with a CF screen positive inconclusive diagnosis (SPID).

2. If not yet doing lung function.

3. If has any other self-identified physical disability which may limit physical activity.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis in Children
• Fibrosis

Intervention

Other:
• No intervention will be provided
No intervention will be provided, this is an observational study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GPAQ	Activity questionnaire for parents	Reviews the past 7 days activities.
Secondary	CPAQ	Physical activity Questionnaire for children aged 5-11 (From medical notes)	Reviews the past 7 days activities.
Secondary	YPAQ	Physical activity Questionnaire for children aged 12 and over (From medical notes)	Reviews the past 7 days activities.
Secondary	Ineb adherence	Adherence to recommended number of nebulised treatment from the i-adhere software downloaded from the ineb device.	1 year
Secondary	Lung function	FEV1 (z-score and %), FVC (z-score and %), FEF2575 (z-score and %) (From medical notes)	Best score in the last 1 year.